NCT00511095

Brief Summary

The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

July 25, 2007

Results QC Date

March 1, 2017

Last Update Submit

April 16, 2019

Conditions

Hepatitis B

Keywords

Hepatitis B vaccineHBV vaccineHepatitis BHepatitisHBVVaccine1018HBsAg

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Local and Systemic Post-injection Reaction Rates

    Local and Systemic post-injection reactions.

    Within 7 days post-injection for post-injection reactions at Week 0 and Week 4

Secondary Outcomes (2)

  • Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.

    Weeks 4, 8, 12 and 28

  • Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28

    Weeks 4, 8, 12, and 28

Study Arms (1)

HEPLISAV

EXPERIMENTAL

0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL

Biological: HEPLISAV

Interventions

HEPLISAVBIOLOGICAL

Intramuscular (IM) injections 0.5mL on Day 0 and Week 4

HEPLISAV

Eligibility Criteria

Age11 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Willing and able to give written informed consent
  • Women of childbearing potential must be willing to consistently use a highly effective method of birth control

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Any previous HBV infection
  • Previous vaccination (1 or more doses) with any HBV vaccine
  • Any previous autoimmune diseases
  • Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
  • Received any blood products or antibodies within 3 months prior to study entry
  • Ever received an injection with DNA plasmids or oligonucleotides
  • Received any vaccines within 4 weeks prior to study entry
  • Received any other investigational medicinal agent within 4 weeks prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beeghley Medical Park

Boardman, Ohio, 44512, United States

Location

Family Healthcare Partners

Grove City, Pennsylvania, 16127, United States

Location

Pediatric Alliance Southwestern

Pittsburgh, Pennsylvania, 15217, United States

Location

Primary Physicians Research

Pittsburgh, Pennsylvania, 15241, United States

Location

Family Practice Medical Associates South

Upper Saint Clair, Pennsylvania, 15241, United States

Location

The Washington Hospital Family Medicine

Washington, Pennsylvania, 15301, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis BHepatitis

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Robert Janssen MD \ VP & Chief Medical Officer
Organization
Dynavax Technologies, Inc.
510-848-5100

Study Officials

  • Eduardo Martins, MD, DPhil

    Dynavax Technologies Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2007

First Posted

August 3, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

March 1, 2008

Last Updated

April 30, 2019

Results First Posted

April 12, 2017

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(7)